BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 22391663 · Received July 2, 2025

    Report

    Report Number
    9611451-2025-00616
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    June 9, 2025
    Report Date
    December 11, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012454560
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE 950N40 NEONATAL OPTIFLOW¿ JUNIOR HEATED CIRCUIT KIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THAT PRODUCT IS THE 950N40J NEONATAL OPTIFLOW¿ JUNIOR HEATED CIRCUIT KIT. THE 510(K) FOR THAT PRODUCT IS K220703. THE SUBJECT DEVICE HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE 950N40 NEONATAL OPTIFLOW¿ JUNIOR HEATED CIRCUIT KIT IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THAT PRODUCT IS THE 950N40J NEONATAL OPTIFLOW¿ JUNIOR HEATED CIRCUIT KIT. THE 510(K) FOR THAT PRODUCT IS K220703. METHOD: THE INSPIRATORY TUBING OF THE SUBJECT 950N40 NEONATAL OPTIFLOW JUNIOR HEATED CIRCUIT KIT WAS RECEIVED AT FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR INVESTIGATION. OUR INVESTIGATION IS THEREFORE BASED ON THE EVALUATION OF THE SUBJECT DEVICE, THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE INSPIRATORY TUBING OF THE 950N40 NEONATAL OPTIFLOW JUNIOR HEATED CIRCUIT KIT HAD MELTED. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THE TUBING WAS COVERED BY A PILLOW AT THE TIME OF THE REPORTED EVENT. VISUAL INSPECTION OF THE SUBJECT DEVICE IDENTIFIED THAT A SECTION OF THE INSPIRATORY TUBE, APPROXIMATELY 70 MM, WAS OBSERVED TO HAVE UNCOILED, CONFIRMING THE REPORTED FAULT. CONCLUSION: BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, EVALUATION OF THE SUBJECT DEVICE AND OUR KNOWLEDGE OF THE PRODUCT, THE CAUSE OF THE MELTED INSPIRATORY TUBING OF THE 950N40 NEONATAL OPTIFLOW JUNIOR HEATED CIRCUIT KIT IS LIKELY DUE TO THE TUBING BEING COVERED IN CONJUNCTION WITH LOW OR NO FLOW RATE. ALL HEATED BREATHING TUBES AS PART OF THE 950N40 NEONATAL OPTIFLOW JUNIOR HEATED CIRCUIT KIT ARE VISUALLY INSPECTED AND UNDERGO FUNCTIONAL TESTS, INCLUDING TEMPERATURE AND HEATER WIRE RESISTANCE. THE HEATER WIRES ARE 100% VISUALLY INSPECTED USING A CAMERA SYSTEM. THE HEATER WIRES ARE ALSO TESTED FOR RESISTANCE, CONTINUITY, POLARITY, AND PITCH DURING PRODUCTION. ADDITIONALLY, A FUNCTIONAL TEST IS CONDUCTED UNDER LOAD. THE HEATED BREATHING TUBE (HBT) IS DESIGNED TO ENSURE THAT "UNDER NORMAL CONDITIONS" THE SURFACE TEMPERATURE DOES NOT EXCEED 44ºC AS PER ISO 80601-2-74:2021 MEDICAL ELECTRICAL EQUIPMENT: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF RESPIRATORY HUMIDIFYING EQUIPMENT. THE TWO ELASTOMERS USED IN HBT BOTH HAVE A SOFTENING POINT OF 76ºC. THE TUBING WILL ONLY REACH THE SOFTENING POINT IF IT IS COVERED FOR A PROLONGED TIME AND HEAT IS NO LONGER ABLE TO DISSIPATE AWAY FROM THE TUBE. THE KEY FACTORS WHICH DETERMINE WHETHER THE HEAT IS RETAINED IN THE AFFECTED AREA LEADING TO SOFTENING ARE: - THE SURFACE AREA OF THE HBT COVERED BY AN OBJECT - THE DURATION OF TIME THE HBT IS COVERED - THE INSULATING PROPERTIES OF THE OBJECT COVERING THE HBT (I.E., HIGHER THERMAL COEFFICIENT WOULD ALLOW LESS HEAT TO DISSIPATE) - THE GAS FLOW RATE THROUGH THE TUBE (I.E., LACK OF FLOW THROUGH THE TUBE WOULD ALLOW LESS HEAT TO DISSIPATE) THE USER INSTRUCTIONS THAT ACCOMPANY THE 950N40 NEONATAL OPTIFLOW JUNIOR HEATED CIRCUIT KIT STATE THE FOLLOWING: - DO NOT COVER THE CIRCUIT WITH MATERIALS SUCH AS TOWELS, PILLOWS, OR BED LINEN. FAILURE TO COMPLY MAY RESULT IN SKIN BURN. - SET APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS TO MONITOR THERAPY DELIVERY. - DO NOT CRUSH, STRETCH, OR MILK THE TUBING. - ENSURE THERE IS GAS FLOW THROUGH THE TUBING BEFORE CONNECTING TO A PATIENT. - APPROPRIATE PATIENT MONITORING (E.G., OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G., IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM OR DEATH.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN SWEDEN REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF A 950N40 NEONATAL OPTIFLOW¿ JUNIOR HEATED CIRCUIT KIT HAD MELTED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN SWEDEN REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE TUBING OF A 950N40 NEONATAL OPTIFLOW¿ JUNIOR HEATED CIRCUIT KIT HAD MELTED. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370213 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT KIT BTT FISHER & PAYKEL HEALTHCARE LTD 950N40 2102741708 09420012454560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown F&P 950 RESPIRATORY HUMIDIFIER| F&P 950 RESPIRATORY HUMIDIFIER